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PHP 315 Exam 1 Questions And Correct Answers
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PHP 315 Exam 1 Questions And Correct Answers...
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PHP 315 Exam 1 Questions And Correct Answers3 step process for OTC review - ANSWER advance notice of proposed rule making,
tentative final monograph, final monograph
over the counter monograph user fee program - ANSWER charge manufacturer for
using monographs
2 pathways to nonprescription status - ANSWER marketed in accordance with OTC
review monograph for that ingredient
new drug application
types of NDA applications - ANSWER prescription to prescription, direct to
nonprescription, NDA deviation, abbreviated new drug application
considerations in switches (from prescription to otc) - ANSWER safety, methods of use,
efficacy, labeling, etc
2 methods of FDA recall - ANSWER FDA seizes the product and orders it to be held
FDA asks for voluntary recall from manufacturer
who is responsible for notifying sellers of recall - ANSWER manufacturer
class 1 recall - ANSWER dangerous or defective products that predictably could cause
serious health problems or death
class 2 recall - ANSWER products that might cause a temporary health problem or post
only a slight threat of serious nature
, class 3 recall - ANSWER products that are unlikely to cause any adverse health reaction
but violate FDA labeling or manufacturing regulations
what requires labeling and mandatory serious adverse events reporting by
manufacturer, packer, and distributor - ANSWER dietary supplement and
nonprescription drug consumer protection act of 2006
FDA requires standardized what? - ANSWER content and format of labels
what is flag the label - ANSWER a voluntary program to alert consumers on changes to a
product
significant changes that could lead to flag the label - ANSWER expansion or limitation of
the claims, modification of the dosage level, change in active ingredients or directions
for use, new warnings or contraindications
how long should a flag be carried on a label - ANSWER 6 months
what is OTC products advertising regulated by - ANSWER federal trade commission
(FDC)
`FTC truth in advertising law - ANSWER advertising must be truthful and not misleading,
advertisers must be able to substantiate all claims made within the advertisement
3rd class of drugs - ANSWER available without a prescription, but behind the pharmacy
examples of third class drugs - ANSWER pseudoephedrine, naloxone, immunizations
pseudoephedrine quantity limits - ANSWER 3.6 g in one day
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